Working alliance and its relationship to outcomes in a randomized controlled trial (RCT) of antipsychotic medication.
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SUBMITTER: Wykes T
PROVIDER: S-EPMC3565872 | biostudies-literature | 2013 Jan
REPOSITORIES: biostudies-literature
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Working alliance and its relationship to outcomes in a randomized controlled trial (RCT) of antipsychotic medication.
Wykes Til T Rose Diana D Williams Paul P David Anthony S AS
BMC psychiatry 20130115
<h4>Background</h4>Long acting injections (LAI) have been associated with perceptions of coercion in cross sectional studies but there have been no longitudinal studies of the effects on clinical relationships with newer depot medications.<h4>Method</h4>Randomized controlled trial with (50) participants with a diagnosis of schizophrenia randomized to risperidone LAI or oral atypical antipsychotic medication. The main outcome was the Working Alliance Inventory (WAI) with background variables (sym ...[more]
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Project description:BackgroundAs many as 89% of people with Parkinson's disease (PD) develop speech disorders.ObjectivesThis randomized controlled trial evaluated two speech treatments for PD matched in intensive dosage and high-effort mode of delivery, differing in subsystem target: voice (respiratory-laryngeal) versus articulation (orofacial-articulatory).MethodsPD participants were randomized to 1-month LSVT LOUD (voice), LSVT ARTIC (articulation), or UNTXPD (untreated) groups. Speech clinicians specializing in PD delivered treatment. Primary outcome was sound pressure level (SPL) in reading and spontaneous speech, and secondary outcome was participant-reported Modified Communication Effectiveness Index (CETI-M), evaluated at baseline, 1, and 7 months. Healthy controls were matched by age and sex.ResultsAt baseline, the combined PD group (n = 64) was significantly worse than healthy controls (n = 20) for SPL (P < 0.05) and CETI-M (P = 0.0001). At 1 and 7 months, SPL between-group comparisons showed greater improvements for LSVT LOUD (n = 22) than LSVT ARTIC (n = 20; P < 0.05) and UNTXPD (n = 22; P < 0.05). Sound pressure level differences between LSVT ARTIC and UNTXPD at 1 and 7 months were not significant (P > 0.05). For CETI-M, between-group comparisons showed greater improvements for LSVT LOUD and LSVT ARTIC than UNTXPD at 1 month (P = 0.02; P = 0.02). At 7 months, CETI-M between-group differences were not significant (P = 0.08). Within-group CETI-M improvements for LSVT LOUD were maintained through 7 months (P = 0.0011).ConclusionsLSVT LOUD showed greater improvements than both LSVT ARTIC and UNTXPD for SPL at 1 and 7 months. For CETI-M, both LSVT LOUD and LSVT ARTIC improved at 1 month relative to UNTXPD. Only LSVT LOUD maintained CETI-M improvements at 7 months. © 2018 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.
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Project description:Adherence to antipsychotic medication is a significant challenge among homeless patients. No experimental trials have investigated the impact of Housing First on adherence among patients with schizophrenia. We investigated whether Housing First in congregate and scattered-site configurations resulted in superior adherence compared to usual care. Adult participants (n = 165) met criteria for homelessness, schizophrenia, and initiation of antipsychotic pharmacotherapy prior to recruitment to an unblinded, 3-arm randomized controlled trial in Vancouver, Canada. Randomization arms were: congregate Housing First (CHF) with on-site supports (including physician and pharmacy services); scattered-site Housing First (SHF) with Assertive Community Treatment; or treatment as usual (TAU) consisting of existing services. Participants were followed for an average of 2.6 years. Adherence to antipsychotic medication was measured using the medication possession ratio (MPR), and 1-way ANOVA was used to compare outcomes between the 3 conditions. Data were drawn from comprehensive pharmacy records. Prior to randomization, mean MPR among participants was very low (0.44-0.48). Mean MPR in the follow-up period was significantly different between study arms (P < .001) and approached the guideline threshold of 0.80 in SHF. Compared to TAU, antipsychotic adherence was significantly higher in SHF but not in CHF. The results demonstrate that further implementation of SHF is indicated among homeless people with schizophrenia, and that urgent action is needed to address very low levels of antipsychotic adherence in this population (trial registration: ISRCTN57595077).
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Project description:Approximately 5% of patients with sarcoidosis have clinically manifest cardiac involvement. Clinical features of Cardiac Sarcoidosis are dependent on the location, extent, and activity of the disease. First line therapy is usually with prednisone and this is recommended based on clinician experience, expert opinion and small observational cohorts. There are no published clinical trials in cardiac sarcoidosis and multiple experts in the field have called for randomized clinical trials to answer important patient care questions. Corticosteroid are associated with multiple adverse effects including hypertension, diabetes, weight gain, osteoporosis, and increased risk of infections. In contrast Methotrexate is generally well tolerated and is increasingly used in other forms of sarcoidosis.ObjectivesThe Cardiac Sarcoidosis Multi-Center Randomized Controlled Trial (CHASM CS-RCT; NCT03593759) is a multicenter randomized controlled trial designed to evaluate the optimal initial treatment strategy for patients with active cardiac sarcoidosis. We hypothesize that (1) a low dose prednisone/methotrexate combination will have non-inferior efficacy to standard dose prednisone and that (2) the low dose prednisone/ methotrexate combination will result in significantly better quality of life than standard dose prednisone, as a result of reduced burden of side effects.Methods/designEligible study subjects will have active clinically manifest cardiac sarcoidosis presenting with one or more of the following clinical findings: advanced conduction system disease, significant sinus node dysfunction, non-sustained or sustained ventricular arrhythmia, left ventricular dysfunction or right ventricular dysfunction. Subjects will be randomized in a 1:1 ratio to prednisone 0.5 mg/kg/day for 6 months (maximum dose 30 mg daily) OR to prednisone 20 mg daily for 1 month, then 10 mg daily for 1 month, then 5 mg daily for one month then stop AND methotrexate 15-20 mg once weekly for 6 months. The primary endpoint is summed perfusion rest score on 6-month PET (blinded core-lab review). The summed perfusion rest score is measure of myocardial fibrosis/scar. The design is non-inferiority with a sample size of 97 per group.DiscussionGiven the multiorgan system potential adverse side effects of prednisone, proving noninferiority of an alternate regimen would be sufficient to make the alternative compare favorably to standard dose steroids. This is the first ever clinical trial in cardiac sarcoidosis and thus in addition to the listed goals of the trial, we will also establish a multi-center, multinational cardiac sarcoidosis clinical trials network. Such a collaborative infrastructure will enable a new era of high quality data to guide physicians when treating cardiac sarcoidosis patients.
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Project description:BackgroundWarfarin is an oral anticoagulant medication that disrupts the liver's production of clotting factors. While this medication is highly effective for the prevention of thromboembolic events, it also has a narrow therapeutic range and a vulnerability to interactions with other drugs and vitamin K-containing foods. Warfarin is commonly ingested at dinnertime, the same time of day that dietary vitamin K consumption (found largely in green leafy vegetables) is most variable. While the long half-life of warfarin might make this irrelevant, the ultra short half-life of vitamin K and the possibility of a hepatic first-pass effect for warfarin make it worth evaluating whether morning ingestion of warfarin, when vitamin K levels are consistently low, leads to greater stability of its anticoagulant effect. An examination of the timing of administration on the effectiveness of warfarin has never before been conducted.Methods/designThis is a 7-month Prospective Randomized Open Blinded End-point (PROBE) study in which established evening warfarin users (primary care managed Canadian outpatients in the provinces of British Columbia and Alberta) will be randomized to either switch to morning ingestion of warfarin (the intervention) or to continue with evening use (the control). The primary outcome is the percent change in the proportion of time spent outside the therapeutic range of the international normalized ratio (INR) blood test. Secondary outcomes include change in proportion of time spent within the therapeutic INR range (TTR), percentage of patients with TTR >75 %, percentage of patients with TTR <60 %, and major warfarin-related cardiovascular events (including all-cause mortality, hospitalization for stroke, hospitalization for GI bleeding, and deep venous thrombosis/pulmonary embolism). We will also compare whether day-to-day variability in the consumption of high vitamin K-containing foods at baseline affects the baseline TTR in this cohort of evening warfarin users.DiscussionThis study addresses whether the timing of warfarin ingestion influences the stability of its anticoagulant effect. Should morning ingestion prove superior, the safety and effectiveness of this medication, and hence the prevention of stroke, pulmonary embolus, and major hemorrhage, could potentially be improved with no added cost or inconvenience to the patient.Trial registrationClinicalTrials.gov: NCT02376803 . Registered on 25 February 2015.
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Project description:IntroductionWe explored the working alliance as measured by both clients and therapists. The working alliance has been known to predict the outcome of psychotherapy and is often considered an important common factor. This study raised the question of how to conceptualize the working alliance in the blended format.MethodsThis was an exploratory study derived from a randomized controlled trial comparing bCBT and face-to-face cognitive behavioural therapy (ftf CBT) on depression. The change in depressive symptoms was measured with the Patient Health Questionnaire (PHQ-9) and the working alliance was measured using the Working Alliance Inventory.AnalysesCorrelation coefficients were calculated for the working alliance as reported by clients and therapists, working alliance was then examined at item and dimension level (task, bond, goal). Linear regression models were applied to investigate the predictive value of the working alliance on treatment outcome. Interaction between the level of working alliance and treatment condition was also considered.ResultsClient and therapist working alliance ratings correlated at r = 0.44 and clients rated the working alliance higher than therapists (x̄ clients = 48.6, x̄ therapists = 44.6). ftf CBT and bCBT had comparable joint working alliance ratings (x̄ ftf = 46.4, x̄ bCBT = 46.8). Items had little deviation apart from item 4 with high positive values. The level of working alliance from the total sample did not significantly predict outcome based on the client's perspective. Contrarily, seen from the therapist's perspective, it did (b = 0.00, p = .044). Using the mean from these predictors as a composite variable, was also significant (b = 0.00, p = .039, R2 adj = 0.07). There was no significant interaction with treatment condition.DiscussionClients and therapists may lay emphasis on different aspects of the working alliance. The finding that therapist-rated working alliance was better than client working alliance at predicting outcome went against common findings; this pattern may be specific to bCBT.ConclusionClients rated the working alliance slightly higher than therapists on average. Clients and therapists as well as treatment conditions had different profiles on dimension deviations. Therapist ratings of the working alliance appeared to better predict treatment outcome than client ratings. Joint working alliance predicted outcome using client and therapist composite means. The working alliance was equally strong in ftf CBT and bCBT. The absence of interaction with treatment condition indicated that the working alliance was equally predictive of outcome in ftf CBT as in bCBT.
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2024-06-13 | PXD046061 | Pride
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